Skip to Main Content

Software Quality Assurance Engineer

STRATFORD SOLUTIONS INC
Colorado Springs, CO
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Job Title: Software Quality Assurance Engineer II

Job Location: Colorado Springs, CO

Job Type: 12 Months Term

Job Pay Rate: $40/hr

Summary

In this role, you have the opportunity to Support New Product Development projects within Image Guide Therapy (IGT) with respect to software, firmware, and hardware from a software design quality assurance perspective.

Roles & Responsibilities

You are responsible for:

• Leading the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.

• Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software.

• Support in the creation and review of all medical device software documentation including cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.

• Understanding of all aspects of the QMS related to Design Controls. 21 CFR 820, ISO 13485

• Development and status reporting of Quality and Reliability metric during phase reviews.

• Participate in Design Verification Planning, Protocol Review, Report Review.

• Participate in Design Validation Planning, Protocol Review, Report Review.

• Participate in Process Validation Planning, Protocol Review, Report Review.

• Provide Guidance on Quality aspects of PDLM Deliverables in addition to Design Verification/Validation.





To succeed in this role, you should have the following skills and experience

• Electrical, Computer/Software, or Biomedical Engineering degree. Engineering or related Science degree.

• 3+ years of software quality or electrical engineering experience.

• ASQ-CQE preferred.

• Expertise in applying IEC 60601 and working knowledge with IEC 62304 and other relevant medical device standards

• Knowledge in electrical and electronic manufacturing processes

• Experience with software development lifecycle mythologies including Agile and SAFe

• Familiar with systems engineering tools including software tools such as, design traceability, defect tracking and management tools such a Jira or Clearquest

• Statistical software solutions such as JMP or Minitab

• Design for reliability concepts and relating complaint history to reliability goals on new projects

• Strong leadership skills and ability to work in a team environment

• Highly motivated hands-on engineer with a proven record of meeting timelines and goals

• Must possess strong analytical & problem-solving skills

• Non-Product Software Validation, IQ OQ PQ

• Non-conforming product investigation, issue and defect tracking, CAPA

• Post Market Surveillance and complaint review

You are a part of:

Our solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology.

STRATFORD SOLUTIONS INC

Address

Colorado Springs, CO
USA

Industry

Technology

View all jobs at STRATFORD SOLUTIONS INC